Teva Pharmaceutical Industries Ltd. TEVA announced that the FDA has approved its biosimilar to Amgen’s AMGN blockbuster drug, ...

Teva’s biosimilar, PONLIMSI™, is now FDA-approved across all indications of the reference product, Prolia® (denosumab), to ...

After biosimilars launch, it can take years for them to gain a foothold. In 2023, Humira biosimilars made barely a dent in the market, and in 2024 they accounted for only about a quarter of sales, ...

The Food and Drug Administration has approved Teva's Prolia biosimilar and the agency is reviewing Teva's Xolair biosimilar application.

The FDA approval for Ponlimsi is based on comprehensive evidence, including analytical and clinical data.

Federal regulators are trying to make it easier to develop cheaper alternatives to powerful drugs that many Americans depend on to treat autoimmune diseases or cancers. The Food and Drug ...

Forbes contributors publish independent expert analyses and insights. Joshua Cohen is a Boston-based writer who covers health policy. Biosimilars are gradually making inroads in the outpatient drug ...

Lawmakers preserve competition to keep prescription drugs affordable for Floridians Health care and prescription drug costs ...

The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. with a fresh draft guidance proposing more changes to streamline development of the cheaper biologic copies.

Johnson & Johnson JNJ, via its Innovative Medicine segment, markets a broad portfolio of blockbuster therapies across key ...

While the FDA is streamlining regulation of copycat versions of the expensive drugs that millions take for arthritis, cancer, and other diseases, the U.S. patent office is making it harder for the ...